Freedom System Accessories 00-52002Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00850051034192), received between May 8, 2025 and Dec 23, 2025 — classified as 3 injuries.

The most frequently reported specific device problem is “Use of Device Problem” (2 reports).

6 other recalls cover devices cleared under the same FDA submission (K152178); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryDec 23, 2025Use of Device Problem; Use of Device Problem

  THE PATIENT REPORTED BLISTERS AFTER USING THE DEVICE. THE PATIENT MET WITH IMPLANTING CLINICIAN, WHO STATED THE WOUND SEEMS TO BE SUPERFICIAL. AS OF (B)(6) 2025, THE BLISTERS HAVE NOT GONE. HOWEVER, MEDICAL INTERVENTION WAS NOT REQUIRED. THE COMMERCIAL TEAM MEMBER RECOMMENDED NOT WEARING THE DEVICE DIRECTLY ON THE SKIN. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Blister

  MAUDE report 23882829 ↗
• InjuryDec 9, 2025Use of Device Problem; Use of Device Problem

  THE PATIENT REPORTED THEIR WEARABLE HAS BEEN IRRITATING THEIR SKIN. ADDITIONALLY, THE PATIENT REPORTED A BLISTER. HOWEVER, THE PATIENT DID NOT REQUIRE ANY MEDICAL INTERVENTION. AS OF (B)(6) 2025, THE IRRITATION AND BLISTER HAVE RESOLVED, THE PATIENT IS DOING WELL, AND THEY ARE USING THE DEVICE APPROPRIATELY.

  Patient problems: Blister; Skin Inflammation/ Irritation

  MAUDE report 23762647 ↗
• InjuryMay 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED A RASH DUE TO THEIR WEARABLE. THE PATIENT USED A TOPICAL STEROID AND TOOK A BREAK FROM WEARING THE WEARABLE. AS OF (B)(6) 2025, THE RASH HAS SUBSIDED AND NO FURTHER ISSUES HAVE BEEN REPORTED.

  Patient problems: Rash

  MAUDE report 21983563 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K152178. One submission often covers many models, so check the product and lot details in each record.

• Z-2928-2020 · Jul 15, 2020 · Open, Classified
  StimQ Peripheral Nerve Stimulator System (PNS) Model 1. STQ4-RCV-A0 US and 2.STQ4-RCV-A0 EU - Product Usage: is used for peripheral neural stimulation to provide therapeutic relie
• Z-2929-2020 · Jul 15, 2020 · Open, Classified
  StimQ Peripheral Nerve Stimulator System (PNS) Model FR4A-TRL-AO US - Product Usage: is used for peripheral neural stimulation to provide therapeutic relief for chronic, intractabl
• Z-2932-2020 · Jul 15, 2020 · Open, Classified
  StimQ Peripheral Nerve Stimulator System (PNS) Model STQ4-SPR-BO US - Product Usage: is used for peripheral neural stimulation to provide therapeutic relief for chronic, intractabl
• Z-2933-2020 · Jul 15, 2020 · Open, Classified
  StimQ Peripheral Nerve Stimulator System (PNS) Models: 1. FR4A-RCV-AO US and 2. FR4A-RCV-A0 EU - Product Usage: is used for peripheral neural stimulation to provide therapeutic re
• Z-2930-2020 · Jul 15, 2020 · Open, Classified
  StimQ Peripheral Nerve Stimulator System (PNS) Models: 1. FR4A-TRL-BO US and 2. FR4A-TR-BO - Product Usage: is used for peripheral neural stimulation to provide therapeutic relief
• Z-2931-2020 · Jul 15, 2020 · Open, Classified
  StimQ Peripheral Nerve Stimulator System (PNS) Models FR4A-SPR-BO US - Product Usage: is used for peripheral neural stimulation to provide therapeutic relief for chronic, intractab